MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	93900
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Expulsion (2933)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.Device labeling: instructions for use: ¿inject juvéderm® ultra plus xc applying even pressure on the plunger rod while slowly pulling the needle backward.The wrinkle should be lifted and eliminated by the end of the injection.It is important that the injection be stopped just before the needle is pulled out of the skin to prevent material from leaking out or ending up too superficially in the skin.¿if the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.How supplied: ¿juvéderm® ultra plus xc injectable gel is supplied in individual treatment syringes with 27-g needles for single-patient use and ready for injection (implantation).The volume in each syringe is as stated on the syringe label and on the carton.The contents of the syringe are sterile and non-pyrogenic.Do not resterilize.Do not use if package is opened or damaged.
Event or Problem Description
Healthcare professional reported one syringe of juvéderm® ultra plus xc had an issue with product not passing through syringe during injection.The physician changed the needle to another allergan needle from the same box.Product still would not pass, then popped the needle off and spilled over tray.No patient contact was made.No injuries were reported.Both packaged needles were used.
Additional Manufacturer Narrative
Device analysis: 2 empty syringes of 0.4 ml each received with cap in an opened ultra xc pack.One needle or 2 are stuck in the anti sting cap.No defect observed to both syringes.
Event or Problem Description
Healthcare professional reported one syringe of juvederm ultra plus xc had an issue with product not passing through syringe during injection.The physician changed the needle to another allergan needle from the same box.Product still would not pass, then popped the needle off and spilled over tray.No patient contact was made.No injuries were reported.Both packaged needles were used.

• Brand Name: JUVEDERM ULTRA PLUS XC
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• MDR Report Key: 7541146
• Report Number: 3005113652-2018-00584
• Device Sequence Number: 19190614
• Product Code: LMH
• UDI-Device Identifier: 30888628000104
• UDI-Public: 30888628000104
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2019
• Device Catalogue Number: 93900
• Device Lot Number: H30LA70510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other